Senior Portfolio Lead

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud the foundation of digital trials

Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions

Overview

The Senior Portfolio Lead is operationally responsible for strategic oversight for assigned customers and ensuring consistency of Data Management services across a customers program

The Senior Portfolio Lead is responsible for setting data standards, establishing process improvement and process workflows along with designing optimized clinical data flows across numerous systems and taking part in technology improvement and implementation efforts

The Senior Portfolio Lead manages the development and implementation of new customer technologies and tools, leading cross-functional project teams to map out data needs and advise customers on relevant data strategies

Key Tasks & Responsibilities

Manages Data Management related aspects of a customers program

Responsible for strategic oversight of assigned customer portfolios

Serve as the customers Subject Matter Expert (SME) on data management topics and strategies

Collaborate with study project teams to develop and implement data management strategies, ensuring quality, efficiency, and consistency across customer programs

Provides proactive, timely communication of program status, data trends and issue resolution with internal team and customers

Perform peer reviews of key data management documents and deliverables to ensure quality and consistency across customer programs

Provide training of Data Management staff on customers specific processes

Act as an escalation point for internal teams regarding customer program challenges and issues

Participate in the development and implementation of new customer technologies or tools

Lead cross-functional project teams to map out data needs; advise Customers on relevant data and champions data appropriateness and communicating the opportunities and challenges

Apply data-driven methods to make informed decisions about solutions, deliveries, and teams

Analyze and evaluate current customer processes and data strategies, identifying gaps and opportunities for improvement

Ability to take risks implementing innovative solutions, accelerating value to customers

Ability to work in a global and highly matrixed ecosystem (internal and external) with a high degree of complexity

Education & Experience

Bachelors degree or higher (masters in science preferred) in relevant health science or professional qualification in a relevant scientific/technical discipline preferred

13+ years of experience Life Sciences industry preferred, with extensive experience supporting Pharmaceutical / Biotechnology / Medical Device organizations with a demonstrated successful record of accomplishment of delivering quality and value to clinical teams along with Certified in Clinical Data Management by SCDM preferred

Professional Skills

Ability to proactively make recommendations that optimize clinical data flow and data collection designs as well as identify leading indicators of quality issues and act upon identified clinical data trends

Strong project management skills a history of successful scope management, resource management, financial management, project planning and resource allocation

Strong analytical and strategic thinking skills with proven experience delivering solutions requiring managing complex client relationships, multiple Data Management services and delivering results that exceed customer expectations for service and operational excellence

Strong understanding of Data Management concepts with an ability to implement modern decentralized trials

A detail-oriented team player with strong organizational skills and the ability to multi-task, prioritize and plan within a high-energy, solutions-based environment where the customer comes first

Intellectual curiosity about the science of drug development and how data can best support the scientific goals of a clinical program and how to champion data throughout the clinical development process

Excellent writing and presentation skills with proven experience presenting complex ideas clearly and concisely

Technical Skills

Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel

Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology

Experience with EDC, Clinical Data Management Systems and analytics applications

Experience with Cloud SaaS platforms (preferred)

Experience with data reporting tools such as Qlik, JReview, Spotfire (preferred)

Experience with RBQM methodology preferred

Exposure to CDISC guidelines and standards

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare

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eClinical Solutions is a people first organization

Our inclusive culture values the contribution that diversity brings to our business

We celebrate individual experiences that connect us and that inspire innovation in our community

Our team seeks out opportunities to learn, grow and continuously improve

Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity

Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need